Endoluminal tool deployment system

ABSTRACT

Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/458,060 filed Jun. 9, 2003 which is a continuation-in-part of U.S.patent application Ser. No. 10/346,709, filed Jan. 15, 2003, now U.S.Pat. No. 7,637,905 issued Dec. 29, 2009 and which also claims thebenefit of prior Provisional Application No. 60/471,893, filed on May19, 2003, the full disclosures of which are hereby incorporated hereinby reference.

STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSOREDRESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAMLISTING APPENDIX SUBMITTED ON A COMPACT DISK

Not Applicable

BACKGROUND OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods. More particularly, the present invention relates to devices,systems and methods for use in endoscopic or laparoscopic procedures.

Endoscopy is a form of minimally invasive procedure wherein the interiorof the body is accessed and visualized through an orifice in the body,such as the esophagus or rectum. Such access allows a surgeon orphysician to view and/or treat internal portions of the orifice orinternal tissues or organs which are accessible through the orifice.These procedures may be for diagnostic purposes, such as visualinspection or the removal of a tissue sample for biopsy, or theprocedure may be used for treatment purposes, such as the removal of apolyp or tumor or the restructuring of tissue. While these procedurescan be done using regular open surgery, endoscopy usually involves lesspain, less risk, less scarring, and faster recovery of the patient.

Endoscopy is typically performed with the use of an endoscope, a smallcircular tube containing optical components. Traditional endoscopescomprise a small diameter “snake-like” insertion tube having a distalend which is inserted into the orifice to the desired internal location.Fiber optics extend through the insertion tube and terminate at thedistal end to allow axial viewing from the distal end. Images of theinternal location near the distal end of the endoscope are transmittedto a video monitor for the physician to view. A control handle allowsthe endoscopist to control the direction of the scope and in some cases,permits the actuation of air, water and suction utilities that may berequired for the endoscopy procedure.

Since endoscopes may be used to perform a treatment at an internallocation, some endoscopes are equipped with a lumen through which asurgical instrument or tool may be passed. Generally, the lumen extendsthrough the length of the insertion tube to the distal end so that theend effector of the inserted instrument protrudes from the distal end inthe axial direction. Thus, the instrument is directed in parallel to thefiber optics so that the end effector is positioned along the line ofview.

Such endoscopes have a number of constraints which limit theirusefulness in performing diagnostic and surgical procedures. To begin,surgical instruments and tools are inserted axially through a workinglumen in the endoscope. And, most of these endoscopes only allow axialand rotational movement of the tool beyond the distal end. This helps tomaintain positioning of the tool within the field of view of theendoscope which is also directed axially. However, this limits thevariety and complexity of procedures that may be performed. For example,procedures which involve tissue approximation pose great difficultysince only one portion of tissue may be grasped at a time and lateral,rather than axial, movement may be required. Although steering of anaxially inserted tool may be possible near the distal end, such steeringtypically positions the end effector of the tool out of the field ofview of the axially directed scope.

A similar minimally invasive procedure which overcomes some of theseconstraints is laparoscopy. In laparoscopy, the interior of the body isaccessed and visualized through a small incision. When accessing theabdomen, the incision is usually made in the navel. Laparoscopy wasinitially used by gynecologists to diagnose and treat conditionsrelating to the female reproductive organs: uterus, fallopian tubes, andovaries. It is now used for a wider range of procedures, includingoperations that in the past required open surgery, such as removal ofthe appendix (appendectomy) and gallbladder removal (cholecystectomy).Laparoscopy is performed with a device which allows the surgeon orphysician to view and/or treat internal tissues or organs which areaccessible through the incision. This device is the same or similar toan endoscope, sometimes referred to as a laparoscope. The devicecomprises a small diameter insertion tube having a distal end which isinserted into the incision to the desired internal location. Fiberoptics extend through the insertion tube and terminate at the distal endto allow axial viewing from the distal end. Images of the internallocation near the distal end are transmitted to a video monitor for thephysician to view. Sometimes, access through an incision creates ashorter, straighter and more direct access path than through an orifice.Therefore, some laparoscopes may have a shorter and stiffer insertiontube than some endoscopes.

Although laparoscopes suffer from many of the same limitations asendoscopes, laparoscopy allows additional surgical instruments and toolsto be inserted through separate incisions to perform procedures. Properlocation of the incisions can allow instruments to be positioned invarious directions. Therefore, movement and viewing is not limited tothe axis of the laparoscope and simultaneous viewing of the tissues andthe instruments may be more readily achieved during the procedure.However, these additional benefits are achieved at the cost of increasedinvasiveness. Access paths must be created for the instruments with theuse of trocars requiring general anesthesia, risk of complications andinfection, and increased overall recovery time for the access paths toheal. In addition, access may be difficult or contraindicated in somepatients, particularly in the morbidly obese.

Thus, it would be desired to provide an improved methods, devices andsystems to perform minimally invasive procedures. Particularly, methods,devices and systems which would provide the benefits of endoscopy, suchas lower invasiveness and access to deeply internal locations, with thebenefits of laparoscopy, such as the use of multiple instruments withmovement and viewing along various axes. The devices and systems wouldbe reliable, convenient and easy to use with improved outcomes forpatients due to reduction in invasiveness and therefore risk, cost andrecovery time. At least some of these objectives will be met by theinvention described hereinafter.

In addition, it would be desired to provide improved methods, devicesand systems which would provide improve passage and manipulation throughendovascular passageways. Typical endoscopes have a length in the rangeof 130 to 190 cm and may be used to traverse a variety of tortuous pathswithin the body. For example, endoscopes may be used to access the lowergastrointestinal tract from entry through the anus, sometimes reachingas far as the cecum at the distal end of the colon. The uppergastrointestinal tract may be accessed through the esophagus to thestomach and the upper regions of the small intestine. Achieving accessto any of these regions, particularly through the colon, involvestedious manipulation of the endoscope. Much of this manipulationinvolves torqueing of the endoscope. However, once a substantial lengthof the endoscope has passed into the body, torqueing becomesincreasingly difficult. In addition, accessing such regions usuallytakes place through minimally supported lumens, such as the colon, whichdo not provide resistive strength or through open cavities, such as thestomach, which do not provide particular pathways for the endoscope.This also limits the use of endoscopic access to desired treatmentlocations.

Thus, it would be desired to provide improved methods, devices andsystems to access desired treatment locations. Particularly, methods,devices and systems which would improve the ability to access desiredtreatment locations minimally invasively, particularly endoscopically orlaparoscopically. The devices and systems would be reliable, convenientand easy to use with improved outcomes for patients due to reduction ininvasiveness and therefore risk, cost and recovery time. At least someof these objectives will be met by the invention described hereinafter.

BRIEF SUMMARY OF THE INVENTION

The present invention provides systems, devices and methods forendoscopic procedures involving tissue manipulations beyond thecapabilities of traditional endoscopic instruments. Some embodiments ofthe systems include an elongated main body which is rigidizable and/ortorque transmitting to improve manipulation through passageways in thebody. And, some embodiments of the systems include an elongated mainbody having a scope therethrough and at least one steerable tool armwhich extends from the distal end of the main body. In theseembodiments, the system typically includes two tool arms, each armsteerable to form a curve laterally outward which then bends laterallyinward so that the arms form a an angular or boomerang shape. Inaddition, end effectors extend from the distal ends of each arm for usein manipulation of tissue. The angular shape brings the end effectorstogether in view of the scope for cooperative movements which arecontinuously visible by the surgeon through the scope. In addition, thetool arms may be steerable in any additional direction and may berotateable to allow grasping, pulling, tugging, elevation and morecomplex manipulation of tissue. Thus, the systems and devices of thepresent invention provide many of the capabilities of open surgery orlaparoscopic surgery with an endoscopic approach. In addition, thesystems and devices of the present invention provide improvements inmanipulation for accessing desired treatment locations.

In a first aspect of the present invention, the tool arm(s) comprise ashaft having a proximal end and a deflectable or steerable distal end.In some embodiments, the steerable distal end will be laterallystabilized so that the distal end may be steered, i.e. bent ormanipulated, within a plane but will resist deflection outside of theplane during use. The steering plane will generally be parallel to acentral axis of the scope but may be rotated by rotation of the toolarm. In this way, the arm(s) will maintain stable positioning within thefield of view of the scope and will resist accidental deflection outsideof the field. It may be appreciated that the tool arm may also betranslated axially within the stabilized plane while maintaining viewingwithin the field.

A preferred structure for achieving lateral stability comprises aplurality of adjacent links. Usually, the links are pivotally attachedby hinged structures. In some embodiments, the hinged structurescomprise pivot pins which are disposed parallel to one another andgenerally transverse to the stabilized plane in which the arm may besteered. In other embodiments, the hinged structures comprise male andfemale bearing surfaces which define axes, wherein the axes are disposedin parallel to limit deflection of the distal section to within theplane. A variety of other structures are also available to providelateral stability, such as deployment frames, various shaped linkagesconnected by reinforcements or pullwires, and slotted tubes, to name afew.

Typically, the distal end includes at least two steerable sections,wherein a distal-most steerable section includes a tip section whichcurves in a first direction and wherein an intermediate steerablesection includes a base which curves in the opposite direction, whereboth curves are in the stabilized plane. In some embodiments, the tipsection curve has a radius which is greater than that of the curve ofthe base. To achieved such curvatures, the adjacent links may be shapedto allow substantially continuous deflection. Or, the adjacent links maybe shaped so that the steerable distal end is deflectable to form apredetermined curvature wherein the arm is then restricted from furtherdeflection.

Means for selectively deflecting the distal section of the tool arm(s)often comprise at least one pullwire or one pushwire. Such pull orpushwires may be present in any quantity and arrangement. The means forselectively deflecting the distal section can further include at leastone spring which is configured to straighten the distal section inopposition to the pullwire or pushwire.

In some embodiments, the tool arm includes an end effector disposed atits distal end. A wide variety of end effectors may be used depending onthe procedure or tissue manipulations which are desired. For example,end effectors may include but are not limited to knives, needles,sutures, staplers, fasteners, clippers, electrosurgical or hemostaticcutters and coagulators, laser welders, cryosurgery instruments,secondary scopes, forceps, lasers hooks, tongs, graspers, retractors,probes, clamps, scissors, tissue approximation devices and suctionapplicators. Alternatively, the tool arm may include a tool deploymentlumen through which a tool having an end effector may be passed. Inthese embodiments, the tool arm may include a steering cuff arranged forpassage of; the tool therethrough so that manipulation of the toolwithin the steering cuff steers the distal end of the tool arm. Thus, ineither case, manipulation of the end effector and the tool arm may beinterconnected.

In another aspect of the present invention, the elongated main body hasa distal end, a proximal end, and an arm guide lumen extending throughat least a distal section of the elongated main body. In preferredembodiments, the elongated main body has a viewing or scope lumenextending therethrough and terminating in the distal tip. It may beappreciated that the scope lumen may be used for passage of any viewingelement or device or the scope lumen may comprise a viewing element ordevice fixed or integrated within the main body. Herein, it will beassumed that the term “scope lumen” will be used to refer to either ofthese embodiments.

The arm guide lumens and the viewing scope lumen may be arranged in anysuitable fashion within the main body. For example, when the elongatedmain body has a second arm guide lumen, the distal terminations of thetwo arm guide lumens and the one viewing scope lumen may be arranged ina generally triangular pattern on the distal tip of the main body.Alternatively, the lumens may be aligned, wherein the viewing scopelumen is disposed between the arm guide lumens.

Typically, at least the distal section of the elongated main body issteerable. In some embodiments, the elongated main body comprises afirst section and a second section, the first section disposedproximally of the second section, and the first and second sections areindependently lockable. Thus, the first section may be lockable whilethe second section remains steerable. Such steering may be achieved withmeans for selectively deflecting the second section within at least asingle plane. This may include retroflexion wherein the distal end ofthe main body is directed toward the proximal end. In some embodiments,the distal section of the elongated main body comprises a plurality ofadjacent links to allow for such steering.

Typically, at least the distal section of the elongated main body has agenerally cylindrical exterior wherein the arm guide lumen does notextend out of the cylindrical exterior. And, the arm guide lumenterminates at a distal tip of the elongated main body so that the toolarm advances through the distal tip. Likewise, as mentioned previously,the elongated main body typically has a viewing scope lumen extendingtherethrough and terminating in the distal tip.

In yet another aspect of the present invention, the tool arms may have adistal end which is steerable by a variety of mechanisms. For example,the distal end may be comprised of a flexible tube having at least onepullwire attached thereto so that manipulation of the at least onepullwire deflects the steerable distal end. Or, the tool arm may have asteerable distal end which comprises a flexible tube having shape memorymaterial so that emergence of the steerable distal end from the distaltip of the main body allows deflection of the steerable distal end to ashape memory position. Or, the tool arm may further comprise adeployment frame extending from the distal tip of the main body, theframe comprising at least two supports each attached to one of the atleast two tool arms so that manipulation of the deployment framedeflects the attached tool arms.

In an additional embodiment of the present invention, the endoluminaltool deployment system may be comprised of an elongated main body havinga distal end, a proximal end, and at least two arm guide lumensextending over or through at least a distal section of the elongatedmain body, wherein said arm guide lumens extend fully to a distal tip ofthe main body, and at least two tool arms adapted to extend through thearm guide lumens of the elongated main body, said tool arms emergingfrom the distal tip of the main body.

In still another aspect of the present invention, the endoluminal tooldeployment system comprises an elongated main body having a distal end,a proximal end, and an arm guide lumen extending through at least adistal section of the elongated main body, wherein at least the distalsection comprises a plurality of adjacent links. The system furtherincludes a means for selectively deflecting the distal section within atleast a single plane, and at least one tool arm adapted to extendthrough the arm guide lumen of the elongated main body.

In a further aspect of the present invention, a method is provided fordeploying one or more tools in an anatomical space. In a preferredembodiment, the method comprises introducing a distal end of a main bodyto said anatomical space, advancing a tool arm from a tool deploymentlumen in said main body into said anatomical space, deflecting andpositioning the tool arm to locate a distal tip thereof adjacent to atarget location within the anatomical space, wherein a distal section ofthe arm is curved and laterally stabilized in a single plane, andadvancing a tool through a lumen of the tool arm to the target location.

In some embodiments, deflecting and positioning comprises tensioning aplurality of adjacent hinged links within the distal section of the toolarm. The adjacent hinged links may be joined by hinge pins which aredisposed perpendicularly to the single plane such that the pinsstabilize the distal section and inhibit deflection outside of thesingle plane. The method may further comprise viewing the targetlocation through a viewing scope disposed in the main body, wherein thetool arm extends axially from a distal tip of the main body from alocation adjacent to the viewing scope.

In some embodiments, an endoluminal system is provided comprising anelongated main body having a proximal end, a distal end sized forpassage through a body lumen, and at least one lumen extending betweenthe proximal and distal ends. The system further includes a torquetransmitting feature which provides torque transmission between theproximal and distal ends while the main body is unlocked and able toform a desired configuration. In addition, the system includes a lockingmechanism which locks the main body in the desired configuration. The atleast one lumen may be used for passage of any desired device,including, for example, a viewing scope and optionally one or more toolarms. In addition, the system typically includes a steering mechanismwhich steers the main body to the desired configuration while the mainbody is unlocked. In most embodiments, the steering mechanism comprisesat least one pullwire extending through the plurality of adjacent links.

In preferred embodiments, at least a portion of the elongated main bodycomprises a plurality of adjacent links. Torque may be transmittedthrough the adjacent links by a variety of torque transmitting features.For example, in some embodiments, when the plurality of adjacent linkscomprises at least a first link and an adjacent second link, the torquetransmitting feature comprising at least one protrusion or tooth fromthe first link slidably engageable with at least one groove in theadjacent second link, the torque transmitting feature providing torquetransmission through the portion of the main body while the links arerotateable. In some embodiments, the at least one protrusion comprises apair of protrusions, each protrusion extending outwardly from an outersurface of the first link in a diametrically opposite position from theother protrusion. Correspondingly, the at least one groove may comprisea pair of grooves, each groove configured to accept one or the pair ofprotrusions passing therein. When the first link comprises a first domedring having the outer surface and the adjacent second link comprises asecond domed ring having an inner surface, the outer surface of thefirst domed ring is mateable with the inner surface of the second domedring along a longitudinal axis, and the rings are rotateable away fromthe longitudinal axis. In some embodiments, each groove comprises afirst groove end and a second groove end, the groove ends substantiallyaligned with the longitudinal axis to allow sliding of the protrusionsalong the grooves during rotation of the rings away from thelongitudinal axis. It may be appreciated that such protrusions mayextend inwardly from an inner surface and the grooves may be disposed onthe outer surface of an adjacent link to accept such protrusions. Thus,the protrusions and associated grooves may function in a similar mannerin an inverse arrangement.

In other embodiments, the torque transmitting feature comprises aprotrusion or a pin from the first link slidably engageable with a slotin the adjacent second link. This is an example of a torque transmittingfeature which provides torque transmission by preventing disengagementof the adjacent links while the main body is unlocked and able to form adesired configuration. In some embodiments, the plurality of adjacentengageable links comprises at least a first link and an adjacent secondlink and the torque transmitting feature comprising at least one pinfrom the first link slidably engageable with at least one slot in theadjacent second link. Further, in some embodiments, the at least one pincomprises a pair of pins, each pin extending outwardly from an outersurface of the first link in a diametrically opposite position from theother pin. Similarly, the at least one slot comprises a pair of slots,each slot configured to accept one or the pair of pins passingtherethrough.

In preferred embodiments, the first link comprises a first domed ringhaving the outer surface and the adjacent second link comprises a seconddomed ring having an inner surface, the outer surface of the first domedring being mateable with the inner surface of the second domed ringsalong a longitudinal axis, and the rings being rotateable away from thelongitudinal axis. Typically, each slot comprises an elongate openingbetween a first slot end and a second slot end, the slot endssubstantially aligned with the longitudinal axis to allow sliding of thepins through the slots during rotation of the rings away from thelongitudinal axis. It may be appreciated that such pins may extendinwardly from an inner surface and extend through slots on adjacentlinks. Thus, the pins and associated slots may function in a similarmariner in an inverse arrangement.

In yet other embodiments, the torque transmitting feature comprises atorque transmitting covering over the plurality of adjacent engageablelinks to prevent disengagement of the adjacent links. In some instances,the torque transmitting covering comprises a snuggly fit sheathincluding reinforcements, such as a braided material. The reinforcementsmay comprise nylon, polyurethane, polyethylene, Teflon, metal, orpolymer, for example. Optionally, the reinforcements may be coated witha polymer or the reinforcements may be covered with a separate polymercomponent. Alternatively, the torque transmitting covering may comprisea polymer coating over the links themselves.

In still further embodiments, an endoluminal device is providedcomprising an elongated main body having a proximal end, a distal end,and at least one lumen extending between the proximal and distal ends,at least a portion of the elongated main body comprising at least afirst link and an adjacent second link which are rotateable relative toeach other when unlocked, one of the at least one lumen extendingthrough the links having at least one partition. An elongated shaft ispresent passing through one of the at least one lumen in a manner totransmit torque by contacting the least one partition. In addition, alocking mechanism is provided which locks the links upon actuation bypreventing rotation of the links relative to each other.

In some embodiments, the at least one partition comprises an inwardprotrusion. And, the at least one lumen extending through the links mayhave a fluted shape forming the inward protrusions. In otherembodiments, the at least one partition comprises a divider spanningacross the one of the at least one lumen. The shaft passes through theat least one lumen and is positioned between partitions in each of thelinks. Torqueing of the plurality of adjacent links is transmittedthrough the shaft and partitions. For example, by applying torque to afirst link, the first link rotates about the longitudinal axis until theshaft contacts a partition. Since the partitions are generally aligned,the shaft will also contact partitions in a second link. Therefore,torque is transmitted from the first link to the second link. Thistransmission may be repeated through any number of links, transmittingtorque through a plurality of adjacent links.

In additional embodiments, the torque transmitting feature comprises anoval shape of the plurality of adjacent links. And, in otherembodiments, the torque transmitting feature comprises a plurality ofwires or rods extending through the adjacent links. In preferredembodiments, the plurality of rods comprises approximately 8 to 64 rods.Torque is transmitted from link to link through these torquetransmitting features.

Further, a method of accessing is provided comprising providing anelongated main body having a proximal end, a distal end, a visualizingelement and a locking mechanism, wherein the main body is capable offorming a desired configuration in an unlocked state and holding thedesired configuration in a locked state. The method further includesintroducing the main body through a body passageway in the unlockedstate forming the desired configuration so that the distal end reaches atarget location, actuating the locking mechanism to hold the main bodyin the desired configuration, and viewing the target location with theuse of the visualizing element.

Introducing the main body may comprise allowing the main body to assumea shape of the body passageway in the unlocked state forming the desiredconfiguration. Or, introducing the main body may comprise steering themain body through the body passageway in the unlocked state forming thedesired configuration. In either situation, in some embodiments, themain body comprises a plurality of adjacent links so that actuating thelocking mechanism comprises holding the links in a fixed relation toeach other. In particular, the plurality of adjacent links sometimescomprises a plurality of nestable elements so that holding the linkscomprises wedging the links together to hold them by friction.

When the main body includes at least one lumen extending between theproximal and distal ends, the method may further comprise introducing aninstrument through the at least one lumen. In some embodiments, theinstrument comprises a tool arm. When the elongated main body furtherincludes a visualizing lumen and the visualizing element comprises anendoscope, the method may further comprise positioning the endoscopewithin the visualizing lumen.

Other objects and advantages of the present invention will becomeapparent from the detailed description to follow, together with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a system of the present invention.

FIG. 2 illustrates the system of FIG. 1 in an assembled arrangement.

FIG. 2A depicts the cross-section of the system of FIG. 2, and FIG. 2Bdepicts an alternative cross-section.

FIGS. 3A-3D, 4-6 illustrate possible movements of the steerable distalends of the tool arms.

FIGS. 7A-7B illustrate the use of an embodiment of the system to performa mucosectomy.

FIGS. 8A-8C illustrate an embodiment of the main body in a variety ofpositions.

FIG. 9A shows an embodiment of the shaft of the main body comprised of amultiplicity of nestable elements, and FIG. 9B provides an exploded viewof these elements.

FIGS. 9C-9E provide cross-sectional views of various nestable elements.

FIG. 10A provides an exploded view of nestable elements having apullwire extending through their centers and FIG. 10B provides across-sectional view one of the nestable elements.

FIG. 10C illustrates the nestable elements of FIG. 10A with theinclusion of liners and FIG. 10D provides a cross-sectional view of oneof the nestable elements.

FIGS. 10E-10O illustrate embodiments of the main body.

FIG. 11 illustrates an embodiment of a tool arm.

FIGS. 12A-12B, 13A-13B, 14 illustrate embodiments of adjacent linksdisposed at the distal end of a tool arm.

FIG. 15 illustrates examples of possible deflections or movements of anembodiment of the tool arm.

FIGS. 16A-16B illustrate another embodiment of a tool arm comprising aplurality of adjacent links.

FIGS. 17, 17A-17C illustrate an embodiment of a tool arm which issteerable to a predetermined arrangement.

FIGS. 18A-1813 illustrate the creation of distinct curvatures achievedby separate pullwires.

FIG. 19 illustrates two tool arms steered to a predeterminedarrangement.

FIG. 20 illustrates an embodiment including both links which aresteerable to a predetermined arrangement and links which areunrestrictedly steerable.

FIGS. 21A-21B illustrate an embodiment of a tool arm comprised of aslotted tube.

FIGS. 21C-21D illustrate an embodiment of a tool arm comprised of a tubewherein a pullwire is positioned on the outside of the tube.

FIGS. 21E-21F illustrate an embodiment of a tool arm comprised of apolymer wall co-extruded with shape memory material.

FIGS. 21G-21H illustrate a mechanism for steering the tool armsincluding a deployment frame.

FIGS. 22A-22B, 23, 24 illustrate embodiments of the shaft of the mainbody.

FIGS. 25A-25B provide a view of the proximal end of an embodiment of themain body wherein two tool arms are present, each including a steeringcuff.

FIGS. 26, 27A-27B, 28A-28B illustrate embodiments of a steering cuff.

FIGS. 29, 29A-29D illustrate embodiments of a tool having an endeffector in the form of various types of scissors.

FIG. 30 illustrates an embodiment of the tool having an end effector inthe form of gator toothed graspers.

FIG. 31 illustrates an embodiment of the tool having an end effector inthe form of an articulatable grasper.

FIGS. 32-36 illustrate embodiments of the tool having end effectors inthe form of various shaped retractors.

FIGS. 37A-37B illustrate grasping hooks inserted through auxiliarylumens in the main body and FIG. 37C illustrates a fixation device whichmay be deployed by the tool arms when such grasping hooks are used in aplication procedure.

FIGS. 38, 39, 40A-40B illustrate alternative tools passed throughauxiliary lumens in the main body.

FIG. 41 illustrates a tool passed through an arm guide lumen for use inconjunction with a tool arm.

FIG. 42 illustrates an arm used to cleanse a portion of the main body,particularly the scope lens.

FIGS. 43A-43F illustrate a torque transmitting feature utilizing a toothand groove concept to maintain alignment of the plurality of adjacentlinks at locations along its length.

FIGS. 44A-44D illustrate a torque transmitting feature utilizing a pinand slot concept to maintain alignment of the plurality of adjacentlinks at locations along its length.

FIGS. 45A-45C illustrate the use of a torque transmitting covering overthe plurality of adjacent links providing torque transmissiontherethrough while the links are rotateable.

FIGS. 46A-46D illustrate cross-sectional views of a link wherein one ofthe at least one lumen extending through the links has at least onepartition.

FIG. 46E illustrates a perspective view showing a plurality of links ofthe type shown in FIG. 46B having an elongated shaft passing through alumen defined by the links.

FIGS. 47A-47B illustrate a torque transmitting feature wherein the linkshave an oval cross-section.

FIGS. 48A-48C illustrate a torque transmitting feature comprising aplurality of rods extending through the adjacent links.

DETAILED DESCRIPTION OF THE INVENTION I. Overview

An embodiment of a system 2 of the present invention is illustrated inFIG. 1. The system 2 includes an elongated main body 10 having aproximal end 12 and a distal end 14 terminating in a distal tip 16. Themain body 10 is used to access an internal target location within apatient's body. Typically, the distal end 14 is passed through a bodyorifice and one or more naturally occurring body lumens to the targetlocation, such as in endoscopy, while the proximal end 12 remainsoutside of the body. Therefore, the main body 10 has a deflectableand/or steerable shaft 20, either due to choice of material or design ofthe shaft 20 to include links, hinges, coils or other similar structuresto allow deflection. Thus, FIG. 1 illustrates the main body 10 in adeflected position wherein the body 10 includes curvatures. Suchdeflection and/or steering may be useful in traversing body lumens tothe target location and is achievable by manipulation of a handle 22near the proximal end 12. It may be appreciated, however, that thesystem 2 may be used in laparoscopic procedures wherein such deflectionand/or steering may be less utilized for placement of the main body 10.In either case, rigidization of some or all the shaft 20 may be desired,for example to provide a stable visualization platform. Therefore,portions of the shaft 20 of the main body 10 are lockable to maintain adesired shape and provide rigidity, either due to choice of material ordesign of the shaft 20 to include locking mechanisms, as will bedescribed in later sections.

The main body 10 also includes at least one arm guide lumen 26 whichextends over or through at least a distal section of the main body 10,typically along the majority of the length of the body 10 as shown. Herein FIG. 1, two arm guide lumens 26 are shown, each extending from aposition along the shaft 20 near the proximal end 12 to the distal tip16. In addition, the main body 10 includes a scope lumen 24 whichextends through the shaft 20 to the distal tip 16.

The system 2 also includes at least one tool arm 30, two are shown inFIG. 1, each arm 30 of which is insertable through a separate arm guidelumen 26 as indicated by dashed line. Each tool arm 30 has a proximalend 32, a distal end 34 and a shaft 36 therebetween. The distal end 34is steerable, such as by manipulation of adjacent links as schematicallyindicated. Such steerability may be controlled by a steering cuff 35which is part of the proximal end 32. The shaft 36 is typically flexibleor deflectable to allow deflection of the surrounding main body shaft20. Each tool arm 30 additionally includes a tool deployment lumen 38therethrough.

In this embodiment, the system 2 also includes at least one tool 40, twoare shown in FIG. 1. Each tool 40 includes a distal end 42, a proximalend 44 and an elongate shaft 46 therebetween to allow passage throughthe tool deployment lumen 38 of the arm 30. Each tool 40 has an endeffector 48 disposed at the distal end 42 and optionally a handle 50 atthe proximal end 44 for manipulation of the end effector 48 from outsidethe body. The tool 40 is advanced so that the end effector 48 emergesfrom the distal end 34 of the arm 30.

FIG. 2 illustrates the system 2 of FIG. 1 in an assembled arrangement.Here, the tool arms 30 are shown inserted through the arm guide lumens26 of the main body shaft 20. The steerable distal ends 34 of the arms30 protrude from the distal end 14 of the main body 10 and the proximalends 32 of the arms 30 protrude from the proximal end 12 of the mainbody 10. As shown, the steering cuffs 35 are located at the proximalends 32 of the arms 30. In addition, the tools 40 are shown insertedthrough the tool deployment lumens 38 so that the end effectors 48extend beyond the steerable distal ends 34 of the arms 34. Likewise, theproximal ends 44 of the tools 40 with handles 50 are shown protrudingfrom the steering cuffs 35. Movement of the tools 40 against thesteering cuffs 35 will actuate steering of the distal ends 34 of thearms 30, as will be described in later sections.

FIG. 2A provides a cross-sectional view of system 2 of FIG. 2. Since theshaft 20 of the main body 10 has a generally cylindrical exterior inthis embodiment, the cross-section of the shaft 20 has a circular shape.It may be appreciated that cylindrical shafts may alternatively have anelliptical, oval or oblong cross-section. The shaft 20 has an outerdiameter in the range of about 5 to 25 mm, preferably approximately 14mm. The shaft 20 has a wall 21 with a thickness in the range of about0.5 to 5 mm, preferably about 2-3 mm, defining an inner central lumen23. Within the wall 21 lies various pushwires or pullwires 96,hereinafter referred to as pullwires, for steering the main body 10which may be present in a variety of quantities and arrangements.Alternatively, the pullwires 96 may be present within the central lumen23. At least one arm guide lumen 26, two are shown, extend through thecentral lumen 23. Each arm guide lumen 26 has an inner diameter in therange of about 0.5 to 5 mm, preferably about 4 mm. Positioned within thelumens 26 are the shafts 36 of the tool arms 30. And, likewise,positioned within the shafts 36 are the tools 40. FIG. 2A alsoillustrates the scope lumen 24 which has an inner diameter in the rangeof about 2 to 10 mm, preferably about 4 mm. In this embodiment, the twoarm guide lumens 26 and the scope lumen 24 are arranged in a generallytriangular pattern which is maintained to the distal tip 16, however anysuitable arrangement may be used which allows viewing of the tool arms,particularly the end effectors, by the scope. For example, FIG. 2Billustrates a cross-section of an embodiment wherein the shaft 20 has anoval shape and the arm guide lumens 26 and the scope lumen 24 aregenerally aligned. Here, the scope lumen 24 is disposed between the armguide lumens 26 to facilitate viewing of the tool arms 30. Alsoillustrated in FIGS. 2A and 2B are additional lumens which may be usedfor various needs. For example, an irrigation/suction lumen 60, aninsufflation lumen 56 and an auxiliary lumen 58 may be present, eachhaving an inner diameter in the range of about 0.5 to 5 mm, preferablyabout 2 mm. The auxiliary lumen 58 may be utilized for a variety ofuses, such as insertion of additional tools, such as a macerator, agrasping tool, a cutting tool or a light source, to name a few, for usein conjunction with the end effectors present at the distal ends of thearms 30 or the distal ends of the tools 40 inserted through the arms 30.

FIGS. 3A-3D illustrate a series of movements of the steerable distalends 34 of the tool arms 30. This series serves only as an example, as amultitude of movements may be achieved by the distal ends 34independently or together. FIG. 3A illustrates the distal tip 16 of themain body 10. The scope lumen 24 is shown along with two arm guidelumens 26 terminating at the distal tip 16 and forming a triangularpattern as illustrated in FIG. 2A. FIG. 3B illustrates the advancementof the distal ends 34 of the tool arms 30 through the arm guide lumens26 so that the arms 30 extend beyond the distal tip 16. FIGS. 3C-3Dillustrate deflection of the arms 30 to a preferred arrangement. FIG. 3Cillustrates deflection of the arms 30 laterally outward. This isachieved by curvature in the outward direction near the base 64 of thesteerable distal end 34. FIG. 3D illustrates deflection of the tipsection 66 of the distal end 34 laterally inward achieved by curvaturein the inward direction so that each arm 30 forms a hook shape. Byfacing the tip sections 66 of the arms 30 toward each other as shown,the tip sections 66 are positioned directly in the path of the scopelumen 24. Therefore, when a scope 28 is positioned within the scopelumen 24, the tip sections 66 of the tool arms 30 and any tools 40advanced therethrough, will be visible through the scope 28. In FIGS.3C-3D, deflection of the arms 30 is achieved with the use of adjacentlinks 62 in the areas of desired curvature. Embodiments of such links 62and other mechanisms of deflection will be discussed in later sections.Further, the deflection of FIGS. 3A-3D are shown to be within a singleplane. However, various embodiments include deflection in multipleplanes. Likewise, the arms 30 are shown to be deflected simultaneouslyin FIGS. 3A-3D, however the arms 30 may be deflected selectively orindependently.

FIGS. 4-6 illustrate additional possible movements of the tool arms 30.For example, FIG. 4 illustrates axial movement of the tool arms 30. Eachtool arm 30 can independently move distally or proximally, such as bysliding within the tool deployment lumen 38, as indicated by arrows.Such movement maintains the arms 30 within the same plane yet allowsmore diversity of movement and therefore surgical manipulations. FIG. 5illustrates rotational movement of the tool arms 30. Each tool arm 30can independently rotate, such as by rotation of the arm 30 within thetool deployment lumen 38, as indicated by circular arrow. Such rotationmoves the arm 30 through a variety of planes. By combining axial,lateral and rotational movement, the arms 30, and therefore the tools 40positioned therethrough, may be manipulated through a wide variety ofpositions in one or more planes.

FIG. 6 illustrates further articulation of the tool arms 30. In someembodiments, the arms 30 are deflectable to form a predeterminedarrangement, such as illustrated in FIG. 3D. Typically, when forming thepredetermined arrangement, the arms 30 are steerable up until theformation of the predetermined arrangement wherein the arms 30 are thenrestricted from further deflection. In other embodiments, the arms aredeflectable to a variety of positions and are not limited by apredetermined arrangement. Such an embodiment is illustrated in FIG. 6wherein the arms 30 articulate so that the tip sections 66 curl inwardlytoward the distal tip 16 of the main body 10. Again, the tip sections 66are positioned in front of the scope lumen 24 and scope 28 for viewing.Typically, the tip sections 66 are positioned on opposite sides of acentral axis 31 of the scope 28, wherein the field of view (indicated byarrow 29) spans up to approximately 140 degrees, approximately 70degrees on each side of the central axis 31. In addition, the depth offield is typically in the range of approximately I-10 cm.

As mentioned previously, the endoluminal tool deployment system 2 of thepresent invention may be used to access a various internal tissues ororgans to perform a wide variety of surgical procedures. FIGS. 7A-7Billustrate the use of an embodiment of the system 2 to perform amucosectomy, or removal of a portion of the mucosa and/or submucosa ofthe stomach. FIG. 7A illustrates advancement of the main body 10 throughthe esophagus E to the stomach S. The main body 10 is then steered to adesired position within the stomach S and the stomach mucosa NI isvisualized through the scope 28 at the distal tip 16. Referring to FIG.7B, the tool arms 30 are then advanced through the main body 10 andarticulated. As mentioned, tools 40 may be advanced through the toolarms 30 or an end effector 48 may be disposed at the distal end of eacharm 30. Here, a grasper 80 is disposed at the distal end of one arm 30and a cutter 81 is disposed at the distal end of the other arm 30. Thegrasper 80 is used to grasp a portion of the mucosa M. The graspedportion of mucosa M can then be elevated by rotation or manipulation ofthe tool arm 30. This allows safe resection of the portion of mucosa Mby cutting with the use of the cutter 82, as shown. Manipulation andresection of the tissue is visualized throughout the procedure throughthe scope 28 which is aligned with the tip sections 66, and thereforeend effectors 48.

It may be appreciated that the systems, methods and devices of thepresent invention are applicable to diagnostic and surgical proceduresin any location within a body, particularly any natural or artificiallycreated body cavity. Such locations may be disposed within thegastrointestinal tract, urology tract, peritoneal cavity, cardiovascularsystem, respiratory system, trachea, sinus cavity, female reproductivesystem and spinal canal, to name a few. Access to these locations may beachieved through any body lumen or through solid tissue. For example,the stomach may be accessed through an esophageal approach, the heartthrough a port access approach, the rectum through a rectal approach,the uterus through a vaginal approach, the spinal column through a portaccess approach and the abdomen through a port access approach.

A variety of procedures may be performed with the systems and devices ofthe present invention. The following procedures are intended to providesuggestions for use and are by no means considered to limit such usage:Laryngoscopy, Rhinoscopy, Pharyngoscopy, Bronchoscopy, Sigmoidoscopy(examination of the sigmoid colon, the sigmoid colon is the portion thatconnects the descending colon to the rectum; primarily for diagnosticpurposes, however a biopsy procedure and trans anal micro surgery may beperformed for removing tumors), Colonoscopy (examination of colon; forthe removal of polyps and tumors or for biopsy), andEsophagogastroduodenoscopy (EGD) which enables the physician to lookinside the esophagus, stomach, and duodenum (first part of the smallintestine). The procedure might be used to discover the reason forswallowing difficulties, nausea, vomiting, reflux, bleeding,indigestion, abdominal pain, or chest pain.

In addition, endoscopic retrograde cholangiopancreatography (ERCP) maybe achieved which enables the surgeon to diagnose disease in the liver,gallbladder, bile ducts, and pancreas. In combination with this processendoscopic sphincterotomy can be done for facilitating ductal stoneremoval. ERCP may be important for identification of abnormalities inthe pancreatic and biliary ductal system. Other treatments includeCholecystectomy (removal of diseased gallbladder), CBD exploration (forcommon bile duct stones), appendicectomy (removal of diseased appendix),hernia repair TAP, TEPP and other (all kinds of hernia), fundoplicationand HISS procedures (for gastro esophageal reflux disease), repair ofduodenal perforation, gastrostomy for palliative management of latestage upper G.I.T. carcinoma), selective vagotomy (for peptic ulcerdisease), splenectomy (removal of diseased spleen), gastric restrictiveand malabsorbtive procedures (for morbid obesity), upper and lower G.I.endoscopies (diagnostic as well as therapeutic endoscopies),pyloroplastic procedures (for children's congenital deformities),colostomy, colectomy, adrenalectomy (removal of adrenal gland forpheochromocytoma), liver biopsy, gastrojejunostomy, subtotal liverresection, gastrectomy, small intestine partial resections (forinfarction or stenosis or obstruction), adhesions removal, treatment ofrectum prolaps, Heller's Myotomy, devascularization in portalhypertension, attaching a device to a tissue wall and local drugdelivery to name a few.

II. Main Body

As mentioned previously, the system 2 of the present invention includesan elongated main body 10 having a proximal end 12 and a distal end 14terminating in a distal tip 16. The main body 10 may have a variety offeatures which are present in a variety of combinations. Generally, thefeatures include deflectability, steerability, torqueability,lockability, lumens for the passage of visualization elements, toolarms, and/or instruments, and integral visualization elements, toolarms, and/or instruments, to name a few. In addition, the main body mayhave any of these features throughout any portion of the main body,including the entire length of the main body or individual subportions.

One embodiment of the main body 10 is illustrated in FIGS. 8A-8C, 9A-9D.In this embodiment, the main body 10 includes deflectability and/orsteerability and lumens for the passage of visualization elements, toolarms, and/or instruments, such as scope lumen 24. FIG. 8A illustratesthe main body in a straight configuration. Since the main body 10 isused to access an internal target location within a patient's body, themain body 10 has a deflectable and/or steerable shaft 20. Thus, FIG. 8Billustrates the main body 10 having various curvatures in its deflectedor steered state. In preferred embodiments, the main body 10 issteerable so that the main body 10 may be advanced through unsupportedanatomy and directed to desired locations within hollow body cavities.In some embodiments, the main body 10 includes a first section 90 whichis proximal to a second section 92, as indicated in FIG. 8B. Althoughboth sections 90, 92 are steerable, the first section 90 may be lockedin place while the second section 92 is further articulated. This isillustrated in FIG. 8C, wherein the first section 90 is shown in alocked position unchanged from FIG. 8B and the second section 92 isshown in various retroflexed positions. In retroflexion, the secondsection 92 is curved or curled laterally outwardly so that the distaltip 16 is directed toward the proximal end 12 of the main body 10.Optionally, the second section 92 may also be locked, either inretroflexion or in any other position.

Steering and locking may be achieved by any suitable mechanisms. In someembodiments, the shaft 20 comprises a multiplicity of nestable elements260, as illustrated in FIG. 9A. FIG. 9B provides an exploded view of thenestable elements 260 of FIG. 9A. Here it can be seen that the elements260 are disposed so that a distal surface 262 of one element 260 coactswith a proximal surface 264 of an adjacent element. Each of the nestableelements 260 includes one or more pullwire lumens 98 through whichpullwires 96 pass. The pullwires 96 are used to hold the elements 260 innesting alignment and to provide steering and locking. The pullwires 96preferably are made from a superelastic material, e.g. nickel titaniumalloy, to provide flexibility, kink-resistance and smooth movement ofthe pullwires 96 through the pullwire lumens 98. Alternatively, thepullwires 96 may be made from braided stainless steel, a singlestainless steel wire, poly-para-phenylene terephthalamide (such asKevlar®), a high tensile strength monofilament thread, combinationsthereof or any suitable materials.

Generally, the adjacent surfaces 262, 264 are contoured to mate so thatwhen the pullwires 96 are relaxed, surfaces 262, 264 can rotate relativeto one another. This allows the shaft 20 to form curvatures throughoutits length in any direction. Each pullwire 96 is fixed at its distal endto a specific element 260 along the shaft 20 or to the distal tip 16.When tension is applied to a specific pullwire 96, a curvature forms inthe shaft 20 proximal to the fixation point, thus steering the shaft 20.The pullwires 96 may be arranged in various patterns to achieve steeringin various directions. For example, FIG. 9C is a cross-sectional view ofthe shaft 20 in the first section 90 of FIG. 8B. Here, eight pullwires96 (four pullwires 96 a and four pullwires 96 h) are shown passingthrough the wall 21. Four pullwires 96 a terminate at the distal end ofthe first section 90 and are used to steer the first section 90. Sincethe pullwires 96 a are equidistantly positioned, applying tension to thepullwires 96 a, either individually or in combination, steers the firstsection 90 in any desired direction. The first section 90 may be lockedin place by holding the tension in the pullwires 96 a using any suitablemechanisms. For example, tension may be applied to the pullwires 96simultaneously until the elements 260 are compressed to a state in whichthey are locked by friction wherein the tension is held.

FIG. 9D is a cross-sectional view of the shaft 20 in the second section92 of FIG. 8B. Here, four pullwires 96 b are shown passing through thewall 21. These pullwires 96 b extended through the first section 90, asindicated in FIG. 9C, and terminate near the distal tip 16. Since thepullwires 96 b are equidistantly positioned, applying tension to thepullwires 96 b, either individually or in combination, steers the secondsection 92 in any desired direction. Since the pullwires 96 b also passthrough the first section 90, such steering may also effect thecurvature in the first section 90 when the first section is not locked.However, such effects are minimal, may be counteracted or compensatedfor by steering in the first section 90, and may be avoided by locking.The second section 92 may be also be locked in place by holding thetension in the pullwires 96 b using any suitable mechanisms.

In this embodiment, the wall 21 extends continuously from the proximalend 12 to the distal end 14 with the first and second sections 90, 92determined by the termination points of the pullwires 96 a which extendtherethrough. Alternatively, the first and second sections 90, 92 may becomprised of separate shafts which are coaxially positioned adjacent toone another.

In the embodiment illustrated in FIG. 9B, the nestable elements 260 havea central lumen 23 which passes through the length of the main body 10.Instruments or tools may be passed through this lumen 23, as indicatedin FIGS. 9C-9D, or tubes may be present within the lumen 23 throughwhich instruments or tools may be passed. In preferred embodiments, thenestable elements 260 have holes formed therein so that lumens areformed by alignment of the holes when the elements 260 are stacked. Forexample, FIG. 9E provides a cross-sectional view of a nestable element260 illustrating the holes formed therein which serve as lumens. Asshown, a scope lumen 24, arm guide lumens 26, and auxiliary lumens 58extend through the center of the element 260 while pullwire lumens 98are located around the periphery.

It may be appreciated that pullwire lumens 98 may also extend throughthe center of the element 260. For example, FIG. 10A illustrates anembodiment having a pullwire 96 which extends through the center of thestacked nestable elements 260. FIG. 10A provides an exploded view of thenestable elements 260 wherein the elements 260 are disposed so that adistal surface 262 of one element 260 coacts with a proximal surface 264of an adjacent element. As shown, each of the nestable elements 260includes a pullwire lumen 98 through its center. FIG. 10B provides across-sectional view of a nestable element 260 of FIG. 10A. As shown,the nestable element 260 includes a locking pullwire lumen 98 c having apullwire 96 c therethrough in the center of the element 260 surroundedby various other lumens, such as a scope lumen 24, arm guide lumens 26,auxiliary lumen 58 and various pullwire lumens 98 used for steering.Once the elements 260 are positioned in a desired arrangement, the shaft20 may be locked in place by the central pullwire 96 c. Applying tensionto the pullwire 96 c compresses the elements 260 to a state in whichthey are locked by friction wherein the tension is held.

In addition, liners 266 may be passed through any of the lumens of thestacked nestable elements 260. Such liners 266 form create a continuouslumen connecting the lumen holes of the nestable elements 260. FIG. 10Cillustrates the nestable elements 260 of FIG. 10A with the inclusion ofliners 266 passing through, for example, the arm guide lumens 26.Likewise, FIG. 10D provides a cross-sectional view of a nestable element260 of FIG. 10C. Here, liners 266 are shown positioned through thenestable element 260 forming lumens 24, 26, 58 therethrough. It may alsobe appreciated that liners 266 may extend through pullwire lumens 98 aswell. The liners 266 may be coated on their luminal surface with ahydrophilic coating for reducing friction or the liners 266 may becomprised of a lubricious polymer such as Teflon®, fluoroethylenepolymer (FEP) or the like.

As mentioned previously, it may be appreciated that the shaft 20 of themain body 10 may have a variety of structures to provide features suchas deflectability, steerability, torqueability, lockability,visualization and various tools, etc. Exemplary embodiments ofstructures which provide deflectability, steerability and or lockabilityare described above and provided in co-pending U.S. patent applicationSer. No. 10/281,462 filed Oct. 25, 2002, which is a continuation in partof U.S. patent application Ser. Nos. 10/173,203, 10/173,227, 10/173,238and 10/173,220, all of which were filed on Jun. 13, 2002 and hereinincorporated by reference for all purposes. Also of interest andincorporated by reference for all purposes are co-pending U.S. patentapplication Ser. Nos. 10/281,461 and 10/281,426 each filed on Oct. 25,2002. It is understood that lockablility includes locking the main bodyin a desired configuration to maintain one or more curvatures along itslength. Thus, in these instances the main body is shape lockable.Structures which provide torqueability will be described in latersections, however it is understood that these features are applicable toany of the embodiments described herein.

In addition, it may be appreciated that the main body 10 may becomprised of a traditional endoscope or laparoscope. Exemplaryembodiments of traditional endoscopes are provided in U.S. Pat. Nos.3,948,251; 4,036,218; 4,201,198; 4,224,929; 4,988,171; 5,020,539;5,035,231; 5,068,719; 5,170,775; 5,172,225; 5,187,572; and 5,196,928,all of which are herein incorporated by reference for all purposes. FIG.10E illustrates the shaft 20 of the main body 10 comprising atraditional endoscope 650, or other endoscope, which includes avisualizing element 652 and at least one light source 654. In thisembodiment, the endoscope 650 includes two arm guide lumens 26 for thepassage of tool arms 30. The tool arms 30 each have end effectors 48, asshown, or tools 40 which have end effectors 48 may be advanced through atool deployment lumen 38 in each arm 30. FIG. 10F provides across-sectional view of the shaft 20 of FIG. 10E. FIG. 10G illustratesthe shaft 20 of the main body 10 comprising a plurality of steerableand/or lockable nestable elements 260 and a traditional endoscope 650,or other endoscope, passing therethrough which includes a visualizingelement 652 and at least one light source 654. The endoscope 650 may beadvanceable and/or retractable through an endoscope lumen 656 in theshaft 20 of the main body 10 or may be fixed within the shaft 20. Theendoscope 650 may be positioned so that a distal end 658 of theendoscope 650 is flush with the distal tip 16 of the shaft 20 or isdisposed at any position along the shaft 20 including extending beyondthe distal tip 16, as shown. FIG. 10H provides a cross-sectional view ofFIG. 10G. Here, the wall 21 of the shaft 20 is more clearly visibleincluding pullwires 96 for steering and/or locking. Further, the shaft20 of the main body 10 may include one or more arm guide lumens 26 forthe passage of tool arms 30, as shown in FIG. 10I. The tool arms 30 eachhave end effectors 48, as shown, or tools 40 which have end effectors 48may be advanced through a tool deployment lumen 38 in each arm 30. FIG.10J provides a cross-sectional view of FIG. 10I.

FIG. 10K illustrates the shaft 20 of the main body 10 having an integralor integrated visualizing element 652 and at least one light source 654.Again, the shaft 20 comprising a plurality of nestable elements 260 forsteering and/or locking. Optionally, the shaft 10 may also include alumen 660, illustrated in FIGS. 10M-10N, for passage of a variety oftools, instruments or devices therethrough, including tool arms 30. Or,as shown in FIG. 10O, the shaft 20 having an integral visualizingelement and at least one light source 654 may have individual arm guidelumens 26 for the passage of tool arms 30. It may also be appreciatedthat the tool arms 30 of FIG. 10O may alternatively be fixed or integralwith the shaft 20.

The visualizing elements 652 of any of the embodiments include elementswhich transmit and/or detect a visual image. For example, suchvisualizing elements 652 may include a coherent fiber optic bundle, anultrasound device, and/or charge coupled devices (CCD) for operation inthe visible spectrum of electromagnetic radiation, the infrared spectrumof electromagnetic radiation, the ultraviolet spectrum ofelectromagnetic radiation, and/or the x-ray spectrum of electromagneticradiation.

III. Tool Arms

As mentioned previously, system 2 also includes at least one tool arm30, each arm 30 of which is insertable through a separate arm guidelumen 26 in the main body 10. As shown in FIG. 11, each tool arm 30 hasa proximal end 32, a distal end 34 and a shaft 36 therebetween. Thedistal end 34 is steerable, such as by manipulation of adjacent links 62as schematically indicated. Such steerability may optionally becontrolled by a steering cuff 35, disposed within the proximal end 32.Each tool arm 30 additionally includes a tool deployment lumen 38therethrough.

A. Distal End

FIGS. 12A-12B illustrate an embodiment of adjacent links 62 disposed atthe distal end 34 to allow steerability of the arm 30. Here, links 62are pivotally connected by hinge structures 100. As shown in FIG. 12A,the links 62 are shaped so that connection by the hinge structures 100creates gaps 102 between the links 62 directly opposite to the hingestrictures 100. A pullwire 96 is shown extending through the links 62and terminating at a fixation point 104. Referring now to FIG. 12B,retraction of the pullwire 96 draws the links 62 together, minimizingthe gaps 102 between the links 62. Due to the shape and arrangement ofthe links 62, this movement creates a curve in the arm 30 as shown. Thedistal end 34 may be steered to have any curvature between substantiallystraight and a maximum curvature wherein the gaps 102 are completelyclosed or another limiting feature is established. In some embodiments,up to 360 degree curvature of the distal end 34 is possible. The distalend 34 may be returned to a straightened position by advancement of thepullwire 96 or by the presence of a spring which will straighten thedistal end 34 by recoil force.

FIGS. 13A-13B illustrate a similar embodiment of adjacent links 62disposed at the distal end 34 to allow steerability of the arm 30.Again, links 62 are pivotally connected by hinge structures 100.However, as shown in FIG. 13A, the links 62 are shaped so thatconnection by the hinge structures 100 creates gaps 102 between thelinks 62 on both sides of the hinge structures 100. A pullwire 96 isshown extending through the links 62 and terminating at a fixation point104. Referring now to FIG. 13B, retraction of the pullwire 96 draws thelinks 62 together, minimizing the gaps 102 between the links 62 alongthe pullwire 96 and maximizing the gaps 102 on the opposite side of thehinge structures 100. Due to this shape and arrangement of the links 62,this movement creates a curve in the arm 30 as shown. The distal end 34may also be returned to a straightened position by advancement of thepullwire 96 or by the presence of a spring which will straighten thedistal end 34 by recoil force. However, in this embodiment, the distalend 34 may be deflected or curved in the opposite direction by continuedadvancement of the pullwire 96. Advancement of the pullwire 96 minimizesthe gaps 102 on the opposite side of the hinge structures 100 causing acurvature in the opposite direction. Likewise, a spring may be presentto straighten the distal end 34 from a curvature in this oppositedirection.

FIG. 14 illustrates an embodiment similar to the embodiment illustratedin FIG. 13A-13B. The links 62 are shown pivotally connected by hingestructures 100. Here the hinge structures 100 comprise pivot pins 106which are arranged in parallel to limit deflection to a single plane. Insome embodiments, the hinge structures comprise male and female bearingsurfaces which define axes, wherein the axes are disposed in parallel tolimit deflection of the distal section to within the single plane. Thelinks 62 are shaped so that connection by the pivot pins 106 createsgaps 102 between the links 62. Closure of the gaps 102 on one side ofthe pivot pins 106 simultaneously opens gaps on the other side of thepins 106. FIG. 14 also illustrates an end effector 48 of a tool 40 whichhas been advanced through the tool deployment lumen 38 of the arm 30.

FIG. 15 illustrates examples of possible deflections or movements of thetool arms 30. Here, two arms 30 are shown emerging from the distal tip16 of the elongated main body 10. The distal end 34 of each arm 30 issteerable and comprised of a plurality of adjacent links 62. The arm 30on the left is shown steered to a position wherein the tip section 66 iscurled inwardly forming an almost complete circular shape. In contrast,the arm 30 on the right is shown steered to a position wherein the tipsection 66 is deflected slightly inwardly forming an arc shape. Thus,the arms 30 may be independently steerable to varying degrees ofcurvature. Preferably, the arms 30 are steerable inwardly to performsurgical procedures in cooperation and to maintain visibility throughthe centrally located scope.

FIGS. 16A-16B illustrate another embodiment of a tool arm 30 comprisinga plurality of adjacent links 62. Here, the links 62 are comprised ofdisks 110 having faces which are angled to form gaps 102 between thedisks 110 when the disks 110 are stacked. The disks 110 are connected byone or more wires or ribbons 112. In this embodiment, illustrated inFIG. 16B; two ribbons 112 are present, each at diametrically oppositepositions within the wall of each of the stacked disks 110 so that theangled faces are aligned between the ribbons 112. The ribbons 112 may beembedded in the wall, co-molded with the stacked disks or simplyadvanced through a lumen in the wall. The ribbons 112 maintain relativeposition of the disks 110 and stabilize the steerable distal end 34 tobe deflectable in only a single plane. Also shown in FIG. 16B, lumens114 are present between the ribbons 112 for positioning pullwires 96therethrough. The pullwires 96 pass through the angled portions of thedisks 110 so that application of tension to a pullwire 96 draws theangled faces of the disks 110 together to close the gaps 102therebetween. This in turn widens the diametrically opposite gaps 102creating curvature in the stack.

As mentioned previously, in some embodiments, the arms 30 aredeflectable to form a predetermined arrangement, such as previouslyillustrated in FIG. 3D. Typically, when forming the predeterminedarrangement, the arms 30 are steerable up until the formation of thepredetermined arrangement wherein the arms 30 are then restricted fromfurther deflection. FIG. 17 illustrates an embodiment of such an arm 30comprising a plurality of adjacent links 62 wherein the arm 30 issteerable to a predetermined arrangement. As shown, the distal end 34comprises a base 64 which deflects the distal end 34 outwardly and a tipsection 66 which deflects inwardly. Between the base 64 and tip section66 lies a spacer 68 which is rigid. The spacer 68 may be considered alarger elongate link or simply a straight section. Usage of such spacers68 is optional and may be used to create specific predeterminedarrangements. FIG. 17A is an enlarged view of the tip section 66 whichillustrates the shapes of the links 62 which are pivotally connected byhinge structures 100 formed into the links 62. Gaps 102 are present onopposite sides of the structures 100 to allow curvature of the distalend 34. The size of the gaps 102 will vary due to varying sizes andshapes of the links 64 so that closure of the gaps 102 forms a specificcurvature. This is most easily seen in FIGS. 17B-17C. FIG. 17Billustrates links 62 of the base 64 having varying shapes to create gaps102 of varying size. As shown, a pullwire 96 extends through the links62 along the gaps 102. Applying tension to the pullwire 96 draws thelinks 62 together to close the gaps 102 and to form a predeterminedcurve as in FIG. 17C.

The predetermined arrangement of FIG. 17 includes curvatures in oppositedirections, the base 64 curving laterally outwardly and the tip section66 curving laterally inwardly. These distinct curvatures may be achievedby separate pullwires 96. For example, as shown in FIG. 18A, a firstpullwire 97 a may be positioned along one side of the tool arm 30terminating at a fixation point 104 a located midway along the distalend 34. The links 62 which lie proximally of this fixation point 104 aform the base 64. A second pullwire 97 b may be positioned along theopposite side of the arm 30 terminating at a fixation point 104 blocated at the tip of the distal end 34. Generally, the links 62 whichlie between the fixation point 104 a and the fixation point 104 b formthe tip section 66. Referring now to FIG. 18B, by applying tension tothe first pullwire 97 a, the base curves laterally outwardly, and byapplying tension to the second pullwire 97 b, the tip section curveslaterally inwardly.

FIG. 19 illustrates two tool arms 30 which are steered to apredetermined arrangement. Such steering is achieved with the use ofpullwires 96 as illustrated in FIGS. 18A-18B. Fixation points 104 b arevisible while fixation points 104 a are hidden within the arms 30. Asshown, the links 62 are varied in size and shape to form thisarrangement when tension is applied to the pullwires 96. For example,the links 62 are generally larger thought the bases 64 and smallerthrough the tip sections 66. Further, this embodiment includesstabilizers 120 which pass through the arms 30 for stability.

In some embodiments, the steerable distal end 34 includes both types oflinks, links which are steerable to a predetermined arrangement andlinks which are unrestrictedly steerable. For example, FIG. 20illustrates an embodiment wherein the base 64 is comprised of links 62which are appropriately shaped and sized to deflect laterally outwardlyto form a predetermined arrangement. Such deflection is achieved with apullwire which is hidden from view and terminates midway along thedistal end 34. In this embodiment, the tip section 66 is comprised oflinks 62 which are appropriately sized and shape to deflect laterallyinwardly in an unrestricted fashion. The links 62 of the tip section 66are hinged together by pivot pins 106 to provide support throughout theunrestricted movement. In addition, a tool 40 having an end effector 48is shown passed through the tool deployment lumen 38 in the arm 30. Alsoshown in FIG. 20, the arms 30 are rotated to lie in different planes, afeature which has been described in previous sections.

It may be appreciated that the embodiments which include links may haveany number of links. For example, the steerable distal end 34 may havetwo links 62 which are hinged together by a hinge structure 100. In thisexample, the shaft 36 would direct the first link 62 in a firstdirection and the hinge structure 100 would turn the distal tip 16towards a second direction. The addition of more linkages 62 wouldcreate a smoother curve and/or allow multiple curves throughout thesteerable distal end 34.

Although the previous embodiments of the tool arms 30 have beencomprised of a plurality of adjacent links, it may be appreciated thatthe arms 30 may be comprised of material in any suitable form. Forexample, each arm 30 may be comprised of a polymeric tube which has beenpre-shaped, such as by heat setting, to form a desired curvature. Thepolymeric tube is comprised of a material which is sufficiently flexibleto allow straightening of the curve for delivery through the arm guidelumen 26 and adequately flexible to allow recoiling of the arm 30 toform the desired curvature upon emergence from the lumen 30.

In another embodiment, each arm 30 is comprised of a slotted tube, asillustrated in FIGS. 21A-21B. Referring to FIG. 21A, a tube 130 has aseries of slots 132 along its length. In this embodiment, the slots 132are present along one side of the tube 130 however, it may beappreciated that the slots 132 may be present on both sides of the tubeor along any portion of the tube which is desired to deflect. Referringback to FIG. 21A, the pullwire 96 is positioned within the tube alongthe slots 132 and fixed to the tube 130 at a fixation point 104. Byapplying tension to the pullwire 96, the tube 130 is deflected towardthe pullwire 96 as shown in FIG. 21B. The presence of the slots 132allows the tube 130 to be comprised of a relatively rigid or thickmaterial while deflecting and curving with minimal buckling or impedanceby the tube 130. It may be appreciated that the tube 130 of FIGS.21A-21B may alternatively be a solid-walled tube without slots comprisedof a thinner or more flexible material which itself allows deflectionand curvature with minimal buckling or impedance. Further, each of thefollowing embodiments illustrating various tool arms 30 may be comprisedof solid-walled or slotted tubes, or any other suitable tubeconstruction.

FIGS. 21C-21D illustrate an embodiment of the arm 30 comprised of a tube130 wherein a pullwire 96 is positioned on the outside of the tube 130and fixed to the tube 130 at a fixation point 104. By applying tensionto the pullwire 96, the tube 130 is deflected toward the pullwire 96 asshown in FIG. 21D. Since the pullwire 96 is disposed outside of the tube130, the pullwire 96 forms a tether to the fixation point 104 and doesnot follow along the surface of the tube 130.

FIGS. 21E-21F illustrate an embodiment of the arm 30 comprised of apolymer wall co-extruded with shape memory material, such as nitinolwire. FIG. 21E illustrates the arm 30 in a straightened position,wherein the arm 30 is passed through the arm guide lumen 26, and acurved position, wherein the arm 30 recoils to a shape-memory curve.FIG. 21F provides a cross-sectional view of the arm 30 of FIG. 21Eillustrating shape-memory material 280 distributed within the wall ofthe arm 30.

FIGS. 21G-21H illustrate an alternative mechanism for steering the toolarms 30. Referring to FIG. 21G, the shaft 20 of the main body 10 isillustrated having a pair of tool arms 30 extending therefrom.Surrounding the arms 30 lies a deployment frame 290. The frame 290 iscomprised of a semi-rigid or rigid material, such as stainless steelwire, which provides sufficient strength to apply force to the arms 30.The frame 290 comprises at least two supports 292, each extending fromthe distal tip 16 of the shaft 20 and connecting at a peak 294. Eachsupport 292 attaches to a tool arm 30 at an attachment point 296. Theframe 290 also includes an actuation support 298 extending from thedistal tip 16 to the peak 294. The arms 30 and supports 292, 298 advancefrom the distal tip 16 of the main body 10 to a desired location in thebody in a straight configuration as illustrated in FIG. 21G. Referringto FIG. 21H, application of tension to the actuation support 298 drawsthe peak 294 toward the distal tip 16 causing the supports 292 to bow orbend outward drawing the attached arms 30 outward. Likewise, thesupports 292 may include hinges wherein the supports 292 would bend atthe hinge. Although FIG. 21H illustrates the arms 30 bending at theattachment points 296, it may be appreciated that the arms 30 may bendat any location. Such bending directs the tool deployment lumens 38toward each other to facilitate coordination of tools passedtherethrough. Movement of the peak 294 proximally and distally variesthe curvature of the arms 30 and provides steering. The frame 290 alsoserves to create a working space, restricting surrounding tissue fromencroaching on the arms 30 and tools 40.

In most embodiments, the distal ends of the tool arms are lockable tomaintain a deflected position. Such locking may be achieved by anysuitable mechanisms. When the tool arm is steerable by manipulation ofpullwires or pushwires, the wires may be held in place to lock thedistal end in a desired position. In embodiments comprising amultiplicity of nestable elements through which pullwires pass, thepullwires are typically used to hold the elements in nesting alignmentand to provide steering and locking. By applying tension to thepullwires simultaneously, the elements may be compressed to a state inwhich they are locked by friction wherein the tension is held. Otherlocking mechanism may also be used. Further, the tool arms may be lockedrotationally and axially within the main body to maintain positioning ofthe tool arm in relation to the main body.

B. Shaft

As described previously, the shaft 36 of the tool arm 30 passes thoughthe main body 10. In embodiments wherein the main body 10 isdeflectable, the shaft 36 is also deflectable. However, although it isdesired that the shaft 36 be laterally deflectable, it is also desiredthat the shaft 36 maintain axial rigidity. Any suitable construction maybe used, including a braid reinforced torqueable tube. Additionalembodiments are described below.

FIGS. 22A-22B illustrate embodiments of the shaft 36 comprising a coil140. Here, illustrated in FIG. 22A, the turns of the coil 140 lieadjacent to each other to prevent axial movement and maintain axialrigidity. However, the coil configuration allows deflection of the shaft36 as shown in FIG. 22B.

In another embodiment, illustrated in FIG. 23, the shaft 36 comprises aplurality of adjacent linkages 150. Here, each linkage 150 includes apair of protruding structures 152 on its face and a pair of notches 154on its base. The protruding structures 152 and notches 154 are both arcshaped so that the protruding structures 152 of one linkage 150rotateably interfit with the notches 154 of an adjacently stackedlinkage 150. By alternating the position of the pairs of protrudingstructures 152 and notches 154 as shown in FIG. 23, the shaft 36 isflexible in both lateral bending directions while maintaining stiffnessaxially and in torsion. Also shown are flared lumens 158 which passthrough the protruding structures 152 and the wall of the shaft 36.Flaring allows for a rod or wire passed therethrough to move within thelumen 158 as a linkage 150 rotates over the protruding structure 152.Round pullwire lumens 156 pass through the notches 154 and the wall ofthe shaft 36 as shown. The rod or wire holds the linkages 150 in astacked configuration and optionally may be used to steer the shaft 36.

In another embodiment, illustrated in FIG. 24, the shaft 36 comprises aplurality of adjacent linkages 160 which are also stacked to providelateral deflection while maintaining axial rigidity. Here, each linkage160 includes a pair of protruding structures 162 on its face and a pairof notches 164 on its base. The protruding structures 162 and notches164 are both arc shaped so that the protruding structures 162 of onelinkage 160 rotateably interfit with the notches 164 of an adjacentlystacked linkage 160. By alternating the position of the pairs ofprotruding structures 162 and notches 164 as shown in FIG. 24, the shaft36 is flexible in both lateral bending directions while maintainingstiffness axially and in torsion. In this embodiment, the linkages 150include a central lumen 166 through which a rod or wire is passed. Therod or wire is used to hold the linkages 60 in the stackedconfiguration.

C. Proximal End

The proximal end 32 of the tool arm 30 may simply terminate in anendpiece or connector for passage of a tool 40 through its tooldeployment lumen 38. However, the proximal end 32 may optionally includea steering cuff 35 for steering the tool arm 30, particularly forsteering its distal end 34.

FIG. 25A illustrates an embodiment of the proximal end 12 of the mainbody 10 wherein two tool arms 30 are present, each inserted through anarm guide lumen 26 in the shaft 20 of the main body 10. As shown, eachtool arm 30 includes a steering cuff 35 which remains outside of themain body 10 and the tool deployment lumen 38 is accessible through thesteering cuff 35. FIG. 25B illustrates an alternative embodiment of theproximal end 12 wherein two tool arms 30 are present, each insertedthrough an arm guide lumen 26 through the handle 22 of the main body 10.Again, each tool arm 30 includes a steering cuff 35 which remainsoutside of the main body 10 and the tool deployment lumen 38 isaccessible through the steering cuff 35. This embodiment also includes alocking mechanism 170 on each arm 30. The locking mechanism 170 can bemanipulated, such as by turning a lever 172 shown in FIG. 25B, to lockthe distal end 34 or the tool arm 30 in a steered or deflected position.

FIG. 26 illustrates an embodiment of a steering cuff 35 disposed at theproximal end 32 of a tool arm 30 wherein a tool 40 is passedtherethrough. In this embodiment, the tool arm 30 includes fourpullwires 96 (three are visible in FIG. 26) which are equidistantlypositioned around the perimeter of the shaft 36. The pullwires 96 areused to steer the distal end 34 of the arm 30 as previously described.As shown, the tool 40 has a distal end 42 with an end effector 48 whichemerges from the distal end 34 of the arm 30. Likewise, the tool 40 hasa proximal end 44 which emerges from the steering cuff 35. In thisembodiment, the steering cuff 35 has a funnel shape wherein one end isattached to at least the pullwires 96 and typically additionally to thearm 30 itself. Deflection of the proximal end 44 of the tool 40,indicated by angular arrow 180, presses the proximal end 44 against thesteering cuff 35 which rotates the steering cuff 35 to a deflectedposition, indicated by dashed line. Such rotation applies tension topullwires 96 diametrically opposite to the deflected position asindicated by arrows 182. Such tension steers the distal end 34 of thearm 30. Thus, manipulation of the tool 40 within the steering cuff 35can be used to steer the distal end 34 of the arm 30.

FIGS. 27A-27B and FIGS. 28A-28B illustrate another embodiment of asteering cuff 35. Here, the steering cuff 35 has a sphere shape and isdisposed at the proximal end 32 of the tool arm 30. The tool 40 ispassed through a lumen 184 in the sphere shaped cuff 35 so that thedistal end 42 of the tool emerges from the distal end 34 of the arm 30and the proximal end 44 remains outside of the cuff 35 as shown. In thisembodiment, the tool arm 30 includes four pullwires 96 (three arevisible) which are equidistantly positioned around the perimeter of theshaft 36. The pullwires 96 are used to steer the distal end 34 of thearm 30 as previously described. FIG. 27A illustrates the pullwires 96emerging from the shaft 36 of the arm 30 and attached to the surface ofthe sphere shaped cuff 35. Likewise, FIG. 27B provides a similar view,however in this case the arm 30 is cutaway to reveal the pullwires 96extending through lumens in the shaft 36 and the tool 40 extendingthrough the tool deployment lumen 38. FIG. 28A illustrates theembodiment in the straight position. Deflection of the proximal end 44of the tool 40, indicated by angular arrow 180, presses the proximal end44 against the steering cuff 35 which rotates the steering cuff 35 to adeflected position, as shown in FIG. 28B. Such rotation applies tensionto pullwires 96 diametrically opposite to the deflected position asindicated by arrow 182. Such tension steers the distal end 34 of the arm30. Thus, manipulation of the tool 40 within the steering cuff 35 can beused to steer the distal end 34 of the arm 30.

It may be appreciated that the embodiments of the steering cuff 35depicted in FIG. 26 and FIGS. 27A-27B, 28A-28B may include any number ofpullwires 96 for any desired level of steerability. For example, in eachembodiment, two pullwires 96 may be present disposed on opposite sidesof the steering cuff 35 for movement of the steerable distal end 34 ofan arm 30 in a single plane. This would be the case for laterallystabilized arms 30.

IV. Tool

As mentioned previously, the system 2 also includes at least one tool40. In some embodiments, the tool 40 may simply comprises an endeffector 48 positioned at the distal end of the tool arm 30 wherein theend effector 48 is operated by manipulation of mechanisms which extendthrough the arm 30. In other embodiments, each tool 40 includes a distalend 42, a proximal end 44 and an elongate shaft 46 therebetween to allowpassage through the tool deployment lumen 38 of the arm 30. The shaft 46is typically desired to be a torque-stable tube comprised of anysuitable material, such as a braid or coil-reinforced extrusion. Inthese embodiments, each tool 40 has an end effector 48 disposed at thedistal end 42 and optionally a handle 50 at the proximal end 44 formanipulation of the end effector 48 from outside the body. Thus, thetool 40 is advanced so that the end effector 48 emerges from the distalend 34 of the arm 30.

A wide variety of end effectors 48 may be used depending on theprocedure or tissue manipulations which are desired. For example, endeffectors 48 may include but are not limited to knives, needles,sutures, staplers, fasteners, clippers, electrosurgical or hemostaticcutters and coagulators, laser welders, cryosurgery instruments,secondary scopes, forceps, lasers hooks, tongs, graspers, retractors,probes, clamps, scissors, tissue approximation devices and suctionapplicators.

FIG. 29 illustrates an embodiment of a tool 40 having an end effector 48in the form of scissors 200. Scissors are one of the oldest surgicalinstruments used by surgeons. Scissors are used to perform many tasks inopen surgical procedure but its use in minimal access surgery requiresgreater skill. As shown, the scissors 200 includes two blades 202, afulcrum 204 and force applicators 206. The cutting force of the scissors200 works on the law of lever. The force applied on the blade 202 can becalculated by length of the force applicators 206 and force applied onthe applicators 206. The scissors 200 of the tool 40 do not apply theexact law of lever because of the cylinder action of the long shaft 46,but the design of applicators 206 helps in the amplification of force bylever action. When the blades 202 of the scissors 200 close, its sharpedges grind against each other and any tissue which comes between theblades of scissors will be cut.

The scissors 200 of FIG. 29 provide an example of straight scissorswherein the blades are straight. This is a widely used instrument formechanical dissection in laparoscopic surgery. Other types of scissorsinclude curved scissors 214, illustrated in FIG. 29A, wherein the blade202 of the scissors 214 is shady curved. In some cases curved scissors214 are preferred because the curvature of the blade 202 of thisscissors creates additional angles of manipulation and may provide abetter view through the scope. Other types of scissors include serratedscissors 216 wherein serrated edges 218 prevent the tissue from slippingout of the blades 202. This may be useful in cutting a slippery tissueor ligature. Still other types of scissors include hook scissors 220which encircle a tissue structure before cutting. Since the tissue isheld between its hooked blades, there is minimal chance of slipping. Thehook scissor 220 is especially useful for cutting secured ducts orarteries. Likewise, the cutting of nerve bundles in neurectomy becomesmay benefit from the use of hook scissors 220. Hook scissors 220 arealso helpful in partial cutting of cystic ducts for intra-operativecholangiography. Further, additional types of scissors include microtipscissors 222. One of the main advantages of microtip scissors 222 is tocut ducts partially for facilitating cannulation. Likewise, this scissor222 may be used for cutting the cystic duct for performingintra-operative cholangiogram. Exploration of small ducts like commonbile duct is very helpful with microtip scissors 222 due to its finesmall blades. Fine microtip scissors 222 are also available in curvedform.

FIG. 30 illustrates an embodiment of a tool 40 having an end effector 48in the form of gator toothed graspers 230. These graspers 230 havereverse angled teeth 232 which are capable of providing an aggressivegrip on tissue. In addition, the graspers 230 are cupped to allow tissueto herniated when the tissue is compressed. Thus, the graspers 230 maybe useful for pelviscopy and handling fibrous ovaries and uterinetissue.

FIG. 31 illustrates an embodiment of a tool 40 having an end effector 48in the form of an articulatable grasper 236. The grasper 236 includes anarticulation section 238 between grasper jaws 240 and the shaft 46. Thisallows the grasper 236 to articulate in an additional degree of freedomrelative to tool arm 30.

Embodiments of the tool 40 having an end effector 48 may be in the formof various shaped retractors. Examples of such retractors include anangled retractor 242, (FIG. 32), hooked retractors 244 (FIG. 33-34), atriangular retractor 246 (FIG. 35), and a circular retractor (FIG. 36),to name a few. Each retractor is flexible and allows for manipulation oforgans and tissue structures.

V. Auxiliary Lumens

As mentioned previously, lumens in addition to the scope lumen 24 andarm guide lumens 26 may be present within the main body 10 and may beconsidered auxiliary lumens 58. Such lumens 58 may be used for anypurpose, such as irrigation, suction, insufflation, macerating,illuminating, grasping, or cutting to name a few, and are typically usedin conjunction with the arms 30 and/or tools 40 inserted through thearms 30 or positioned at the ends of the arms 30.

In one embodiment, illustrated in FIG. 37A, grasping hooks 310 areinserted through a single auxiliary lumen or through separate auxiliarylumens 58 (shown) in the shaft 20. The grasping hooks 310 may becomprised of any suitable material, such as shape-memory wire orshapeable polymer, that allows a hook shape to be formed once the hooks310 have emerged from the distal tip 16. In addition, the hooks 310 mayhave a pointed or sharp tip to assist in grasping or piercing tissue.Referring to FIG. 37B, the grasping hooks 310 may be used to grasp aportion of tissue T to create a plication or fold. The tool arms 30 maythen be extended on opposite sides of the folded tissue T to deploy afixation device 312 which will hold the plication in place. FIG. 37Cillustrates such a fixation device 312 comprising a tie 314 passingthrough the tissue T with anchors 316 positioned on either side of theplication. The tie 314 may be comprised of a suture, wire or rod, forexample, and the anchors 316 may be comprised of knots, disks orexpandable umbrellas, to name a few. Such plication procedures may beused for treating gastroesophageal reflux disease (GERD).

Alternatively, other tools may be passed through auxiliary lumens 58 forsimilar or other purposes. For example, a corkscrew device 320 (FIG. 38)or a grasper claw 322 (FIG. 39) may be passed through an auxiliary lumen58 for grasping tissue T. Or, tissue T may be grasped with a suctiondevice. FIG. 40A illustrates a suction device 324 in an undeployedconfiguration. The suction device 324 comprises a deployment sleeve 328which houses an expandable funnel 326. Withdrawal of the deploymentsleeve 328 releases the funnel 326 allowing the funnel 326 toself-expand, as shown in FIG. 40B. The increased surface area of thefunnel 326 allows for adequate suction for grasping tissue T and holdingthe tissue T within the funnel 326.

It may be appreciated that tools 40 may alternatively be passed throughan arm guide lumen 26 for use in conjunction with a tool arm 30 passedthrough another arm guide lumen 26. For example, as illustrated in FIG.41, a macerator 336 may be passed through an arm guide lumen 26 formaceration of tissue T or a blood clot while a tool arm 30 is used forirrigation and aspiration. The macerator 336 macerates the tissue T toform small particles which may be more readily aspirated. Further,irrigation through the arm 30 may be used to cleanse portions of thedevice. For example, as illustrated in FIG. 42, the arm 30 may besteered to face the scope 28 allowing irrigation to cleanse the scope 28thus improving viewing.

VI. Torque Transmission

As mentioned previously, the system 2 of the present invention includesan elongated main body 10 having a proximal end 12 and a distal end 14terminating in a distal tip 16. An embodiment of the main body 10 wasillustrated in various configurations in FIGS. 8A-8C utilizing steeringand/or locking. Steering and locking may be achieved by any suitablemechanisms. In some embodiments, the shaft 20 comprises a plurality ofadjacent links, such as nestable elements 260 illustrated in FIG. 9A.FIG. 9B provided an exploded view of the nestable elements 260 of FIG.9A, illustrating that the elements 260 are disposed so that a distalsurface 262 of one element 260 coacts with a proximal surface 264 of anadjacent element. And, each of the nestable elements 260 includes one ormore pullwire lumens 98 through which pullwires 96 pass. The pullwires96 are used to hold the elements 260 in nesting alignment and to providesteering and locking. Generally, the adjacent surfaces 262, 264 arecontoured to mate so that when the pullwires 96 are relaxed, surfaces262, 264 can rotate relative to one another. This allows the shaft 20 toform curvatures throughout its length in any direction.

In addition to steering with the use of pullwires 96, the main body 10can be manipulated by torqueing. Typically, the distal end 14 of themain body 10 is positioned within the body while the proximal end 12remains outside of the body. It is often desired to rotate the distalend 14 within the body by manually rotating the proximal end 12. Toachieve this effectively, the main body 10 should be capable ofeffectively transmitting torque. To achieve this, particularly throughportions of the main body 10 which include adjacent links, such asnestable elements 260, a torque transmitting feature may be included.

One such torque transmitting feature is illustrated in FIGS. 43A-43F.FIGS. 43A-43F illustrate the use of a tooth and groove concept tomaintain alignment of the plurality of adjacent links at locations alongits length. By maintaining alignment in particular locations, torque maybe more easily transmitted while still allowing freedom of rotation ofthe links for steering.

FIG. 43A is a perspective view of one of the plurality of adjacentlinks, a first link 500. The first link 500 has a top edge 502, a bottomedge 504, an outer surface 506 and an inner surface 508 forming a domedring-like structure having a lumen 505 therethrough. Pullwire lumens 98are shown passing through the inner surface 508 and out through the topedge 502. It may be appreciated that the pullwire lumens 98 may be usedfor other elements, such as support wires or rigidizing wires, howeverat least some of the pullwire lumens 98 are used for passing pullwires96 for steering. The first link 500 also includes a torque transmittingfeature comprising at least one protrusion, such as a tooth 510, whichprotrudes inward from the inner surface 508 in this embodiment. Thetooth 510 may have any suitable shape or size and may extend beyond theedges 502, 504. In this embodiment, the tooth 510 has a first tooth end512 and a second tooth end 514 wherein the first tooth end 512 is flushwith the inner surface 508 and the second tooth end 514 protrudesoutwardly toward the bottom edge 504 of the link 500 forming a wedgeshape. The torque transmitting feature also includes at least one groove516 in the outer surface 506. The groove 516 is sized, shaped andpositioned so that when the first link 500 is engaged with an adjacentlink, the groove 516 in the first link 500 accepts a tooth 510 on theadjacent link.

In some embodiments, a pair of teeth 510, 510′ are present wherein onetooth 510 is located in a diametrically opposite position from the othertooth 510′. Likewise, a pair of grooves 516, 516′ are also presentwherein one groove 516 is located in a diametrically opposite positionfrom the other groove 516′, or 180 degrees apart. Typically, the pair ofteeth 510, 510′ and pair of grooves 516, 516′ are located so that eachare separated by approximately 90 degrees, as shown in FIG. 43A. FIG.43B provides a side view and FIG. 43C provides a partial perspectiveview of the link of FIG. 43A.

The first link 500 is engageable with a series or plurality ofadditional links, each having the same or similar features as the firstlink 500. Such a plurality of adjacent links is shown in FIG. 43D. Here,the first link 500 is shown mated with a second link 520, a third link522, a fourth link 524 and a fifth link 526. The links 500, 520, 522,524, 526 are each individually rotateable by steering, such as with theuse of pullwires 96 as described in related earlier sections. FIG. 43E,illustrates four of these links 500, 520, 522, 524 wherein the outersurface 506 of each link is mated with the inner surface 508 of anadjacent link along a longitudinal axis 530. The first link 500 is shownto have a pair of teeth 510, 510′, one tooth 510 disposed in a positionalong the inner surface 508 which is diametrically opposite to the othertooth 510′. The one tooth 510 is slidably engageable with a groove 516in the outer surface 506 of the adjacent second link 520 and the othertooth 510′ is slidably engageable with a groove 516′ in a diametricallyopposite position in the outer surface 506.

In this embodiment, groove 516 has a first groove end 518 and a secondgroove end 519. The groove ends 518, 519 are substantially aligned withthe longitudinal axis 530 to allow sliding of the tooth 510 along thegroove 516 during rotation of the link away from the longitudinal axis530. Likewise, groove 516′ has a first groove end 518′ and a secondgroove end 519′ in a similar arrangement.

The second link 520 also includes a pair of teeth 510, 510′ which areeach disposed 90 degrees from the grooves 516, 516′. Therefore, only onetooth 510 is visible in the second link 520 since the teeth 510, 510′aligned in the view of FIG. 43E, however it may be appreciated that eachof the pair of teeth 510, 510′ in the second link 520 are slidablyengaged with one of a pair of grooves 516, 516′ in the third link 522.Likewise, the third link 522 is shown to have a pair of teeth 510, 510′,one tooth 510 disposed in a position along the inner surface 508 whichis diametrically opposite to the other tooth 510′. The one tooth 510 isslidably engageable with a groove 516 in the outer surface 506 of theadjacent fourth link 524 and the other tooth 510′ is slidably engageablewith a groove 516′ in a diametrically opposite position in the outersurface 506.

Steering rotates at least some of the links away from the longitudinalaxis 530, such as illustrated in FIG. 43F. Here, the first link 500 isshown rotated along another axis 532 which forms an angle with thelongitudinal axis 530. Such rotation slides the one tooth 510 on thefirst link 500 downward along the groove 516 in the second link 520while the other tooth 510′ slides upward along the groove 516′ in thesecond link 520. Thus, the first link 500 is free to rotate in thisplane. It may be appreciated that each link is free to rotate in atleast a plane defined by the alignment of teeth and grooves. When theposition of such aligned teeth and grooves are varied along the lengthof the plurality of adjacent links, the links are able to rotate invarious directions.

In addition, torqueing of the plurality of adjacent links is transmittedthrough the aligned teeth and grooves. For example, by applying torqueto the fourth link 524, as indicated by arrow 534 in FIG. 43F, thefourth link 524 will rotate about the longitudinal axis 530 until one ofthe grooves 516′ contacts the slidably engaged tooth 510′ whichtransmits the torque to the third link 522. This transmission isrepeated through each of the links, transmitting torque to the firstlink 500.

Another embodiment of a torque transmitting feature is illustrated inFIGS. 44A-44D. FIGS. 44A-44D illustrate the use of a pin and slotconcept to maintain alignment of the plurality of adjacent links atlocations along its length. By maintaining alignment in particularlocations, torque may be more easily transmitted while still allowingfreedom of rotation of the links for steering. In addition, the pin andslot concept prevents disengagement of the adjacent links while the mainbody is unlocked. This further enhances torque transmission.

FIG. 44A is a perspective view of one of the plurality of adjacentlinks, a first link 500. The first link 500 has a top edge 502, a bottomedge 504, an outer surface 506 and an inner surface 508 forming a domedring-like structure having a lumen 505 therethrough. Although pullwirelumens are not shown, it may be appreciated that pullwire lumens may bepresent, for example passing through the inner surface and out throughthe top edge. It may also be appreciated that the pullwire lumens may beused for other elements, such as support wires or rigidizing wires,however at least some of the pullwire lumens are used for passingpullwires for steering. The first link 500 also includes a torquetransmitting feature comprising at least one protrusion, such as a pin550, which protrudes outward from the outer surface 506. The torquetransmitting feature also includes at least one slot 552, providing anopening between the inner surface 508 and the outer surface 506.

In some embodiments, a pair of pins 550, 550′ are present wherein onepin 550 is located in a diametrically opposite position from the otherpin 550′. Likewise, a pair of slots 552, 552′ are also present whereinone slot 552 is located in a diametrically opposite position from theother slot 552′, or approximately 180 degrees apart. Typically, the pairof pins 550, 550′ and pair of slots 552, 552′ are located so that eachis separated by approximately 90 degrees as illustrated.

FIG. 44B provides a side view of the first link 500 of FIG. 44A.Dimensions provided are related to an exemplary embodiment are notintended to be limiting. It may be appreciated that the pin 550 may haveany suitable shape or size and may be positioned anywhere along theouter surface 506. In this embodiment, the pins 550, 550′ each have acylindrical shape with a cross-sectional diameter of approximately0.0325 in. and each is positioned near the top edge 502. Each slot 552is sized, shaped and positioned so that when the first link 500 isengaged with an adjacent link, a slot 552 in the first link 500 acceptsa pin 550 on the adjacent link. Typically, each slot 552 is positionednear the bottom edge 504, preferably 0.010 in. from the bottom edge 504as illustrated in FIG. 44B. Also illustrated in FIG. 44B, each slot 552has a first slot end 554 and a second slot end 556, typicallyapproximately 0.090 in. apart. The slot ends 554, 556 are substantiallyaligned with the longitudinal axis 530 to allow sliding of the pin 550through the slot during rotation of the link away from the longitudinalaxis 530, as will be illustrated in FIGS. 44C-44D.

FIG. 44C illustrates the first link 500 engaged with a second link 520having the same or similar features as the first link 500. The links500, 520 are each individually rotateable by steering, such as with theuse of pullwires 96 (not shown) as described in related earliersections. As shown, the outer surface 506 of each link is mated with theinner surface 508 of an adjacent link along a longitudinal axis 530. Thefirst link 500 is shown to have a pair of slots 552, 552′, one slot 552which is visible in this view. Extending through the one slot 552 is apin 550 which protrudes from the outer surface 506 of the adjacentsecond link 520. It may be appreciated that the second link 520 also hasan additional pin 550′ which passes through slot 552′.

Steering rotates at least some of the links away from the longitudinalaxis 530, such as illustrated in FIG. 44D. Here, the first link 500 isshown rotated along another axis 532 which forms an angle with thelongitudinal axis 530. Such rotation slides one pin 550 on the secondlink 520 upward along the slot 552 in the first link 500 while anotherpin 510′ slides downward along the slot 552′ in the first link 500.Thus, the second link 520 is free to rotate in this plane. It may beappreciated that each link is free to rotate in at least a plane definedby the alignment of pins and slots. When the position of such alignedpins and slots are varied along the length of the plurality of adjacentlinks, the links are able to rotate in various directions.

In addition, torqueing of the plurality of adjacent links is transmittedthrough the aligned pins and slots. For example, by applying torque tothe second link 520, the second link 520 will rotate about thelongitudinal axis 530 until one of the slots contacts the slidablyengaged pin which transmits the torque to the first link 500. Thistransmission may be repeated through any number of links, transmittingtorque through a plurality of adjacent links.

Another torque transmitting feature is illustrated in FIGS. 45A-45C.FIGS. 45A-45C illustrate the use of a torque transmitting covering overthe plurality of adjacent links providing torque transmissiontherethrough while the links are rotateable. FIG. 45A illustrates anembodiment of the torque transmitting covering. In this embodiment, thecovering 570 comprises a sheath 576 having reinforcements 578throughout. Such reinforcements 578 are comprised of nylon,polyurethane, polyethylene, Teflon, metal, polymer or any suitablematerial and are typically braided or woven, however any arrangement ofthe reinforcements 578 may be used. The reinforcements 578 may be dippedin a polymer dispersion in a suitable solvent to coat the reinforcements578. Such coating holds the reinforcements 578 together in a desiredarrangement suitable for torque transmission. Alternatively or inaddition, the reinforcements 578 may be sprayed, painted or otherwisecoated with a polymer. Likewise, other methods of forming the covering570 may be used. It may also be appreciated that the covering 570 may beformed without reinforcements 578. The coating may also be anindependent component that is draped over the reinforcements 578.

The covering 570 may have any suitable size or shape, but is typicallyan elongate tube sized to fit snuggly around the plurality of adjacentlinks which are rotateable relative to each other when unlocked.Typically the covering 570 has a wall thickness in the range ofapproximately 0.005 to 0.015 in., typically in the range ofapproximately 0.010 to 0.015 in. Snug fit of the covering around theadjacent links prevents the links from disengaging while allowing thelinks to rotate during steering. Thus, the covering 570 may also beformed by dipping the adjacent links in a polymer dispersion to form acoating on the links.

FIG. 45B illustrates the covering 570 fit over a series or plurality ofadjacent links (a first link 500, second link 520, third link 522,fourth link 524 and fifth link 526) wherein the outer surface of eachlink is mated with the inner surface of the adjacent link along alongitudinal axis 530. The links 500, 520, 522, 524, 526 are eachindividually rotateable by steering, such as with the use of pullwires96 as described in related earlier sections.

Torqueing of the plurality of adjacent links is transmitted with the useof the covering 570. For example, by applying torque to the fifth link526 and surrounding covering 570, as indicated by arrow 572 in FIG. 45C,the fifth link 526 will rotate about the longitudinal axis 530 alongwith the surrounding covering 570. The torqueing force applied to thecovering 570 will be transmitted along the length of the covering 570from the fifth link 526 toward the first link 500. Since the covering570 is snuggly fit around the links, the links will maintain engagement,assisting in the transmission of torque. Thus, the first link 500 willthen rotate about the longitudinal axis 530, as indicated by arrow 574,in response to the rotation of the fifth link 526.

Another torque transmitting feature is illustrated in FIGS. 46A-46E. Asmentioned, embodiments of the main body typically include a proximalend, a distal end and at least one lumen extending between the proximaland distal ends, at least a portion of the elongated main bodycomprising at least a first link and an adjacent second link which arerotateable relative to each other when unlocked. FIGS. 46A-46Dillustrate cross-sectional views of a link wherein one of the at leastone lumen extending through the links has at least one partition. Forexample, referring to FIG. 46A, a first link 500 is shown having lumen505 extending therethrough. The lumen 505 has two partitions 590, eachpartition 590 having the form of an inward protrusion. Any number ofpartitions 590 may be present, such as two, three, four, five, six,seven, eight or more. For example, FIG. 46B illustrates a first link 500having a lumen 505 with five partitions 590. In this example, thepartitions 590 provide the lumen 505 with a fluted shape. The partitions590 may have any shape, for example, blunt, pointed, rounded, or square,and may extend inwardly any distance. For example, FIG. 46C illustratesa first link 500 having a lumen 505 with partitions 590 which extendfurther into the lumen 505 than in the embodiments of FIGS. 46A-46B.Further, as illustrated in FIG. 46D, the partitions 590 may comprise atleast one divider 592 spanning across the lumen 505 of the link 500forming sub-lumens 594. In addition, also illustrated in FIGS. 46A-46D,the links 500 may also include other lumens, such as steering orpullwire lumens 98 for the passage of pullwires used in steering.

The partitions 590 are used as a torque transmitting feature with theuse of an elongated shaft 600 passing through the lumen 505, asillustrated in FIG. 46E. As shown, the first link 500 is engageable witha plurality of adjacent links, such as a second link 520 and third link522, each having the same or similar features as the first link 500. Inaddition, the links 500, 520, 522 are arranged so that the partitions590 within each link are generally aligned. The shaft 600 passes throughthe lumen 505 and is positioned between partitions 590 in each of thelinks. Torqueing of the plurality of adjacent links is transmittedthrough the shaft 600 and partitions 590. For example, by applyingtorque to the first link 500, the link 500 rotates about thelongitudinal axis 530 until the shaft 600 contacts a partition 590.Since the partitions 590 are generally aligned, the shaft 600 will alsocontact partitions 590 in the second link 520 and third link 522.Therefore, torque is transmitted from the first link 500 to the thirdlink 522. This transmission may be repeated through any number of links,transmitting torque through a plurality of adjacent links.

Another torque transmitting feature is illustrated in FIGS. 47A-47B. Asmentioned, embodiments of the main body typically include a proximalend, a distal end and at least one lumen extending between the proximaland distal ends, wherein at least a portion of the elongated main bodycomprises a plurality of adjacent links. FIG. 47A illustrates a sectionof adjacent links, including a first link 500, a second link 520 and athird link 522, wherein the links have an oval cross-section. Asmentioned previously, and illustrated in FIG. 2B, the links may have anoval shape for a variety of purposes, including providing for a desiredarrangement of, for example, a scope 28 and optionally tool arms 30passing through lumen 505. The oval shape may also function as a torquetransmitting feature. As shown in FIG. 47B, torqueing of the first link500 rotates the first link 500 about the longitudinal axis 530, asindicated by arrows 602. The first link 500 will contact the second link522 due to the oval shape, as shown. This will cause the second link 522to rotate, as indicated by arrows 604. Thus, torque is transmitted tothe second link 522. This transmission may be repeated through anynumber of links, transmitting torque through a plurality of adjacentlinks.

Another torque transmitting feature is illustrated in FIGS. 48A-48C. Asmentioned previously, embodiments of the main body typically include aproximal end, a distal end and at least one lumen extending between theproximal and distal ends, wherein at least a portion of the elongatedmain body comprises a plurality of adjacent links. A cross-sectionalview of one of these adjacent links, such as the first link 500, isshown in FIGS. 48A-48C, wherein each of the links have the same orsimilar cross-section. The torque transmitting feature comprises aplurality of wires or rods 620 extending through the adjacent links.FIG. 48A shows eight rods 620, symmetrically arranged around lumen 505.It may be appreciated, however, that the rods 620 may be present in anyarrangement. When torque is applied to a link which is adjacent to thefirst link 500, the rods 620 passing through the first link 500 transmitthe torque (indicated by arrows 622) to the first link 500 therebyrotating the first link 500. This transmission may be repeated throughany number of links, transmitting torque through a plurality of adjacentlinks. Similarly, FIG. 48B shows sixteen rods 620, symmetricallyarrangement around lumen 505. Again, when torque is applied to a linkwhich is adjacent to the first link 500, the rods 620 passing throughthe first link 500 transmit the torque (indicated by arrows 622) to thefirst link 500 thereby rotating the first link 500. Thus, the more rods620 present the higher the torque transmission. FIG. 48C showsthirty-two rods 620, symmetrically arrangement around lumen 505. Anynumber of rods 620 may be present, typically ranging from eight tosixty-four. It may also be appreciated that the rod 620 may be comprisedof any suitable material, such as metal, metal wire, polymer, nitinol,filament or fiber, to name a few. Also, some or all of the rods 620 maybe pushwires or pullwires 96.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined by the appended claims.

1. A system for providing endoscopic access into the body of a patientfor one or more flexible instruments, comprising: a primary handlehaving a primary steering actuator; a primary shaft attached at aproximal end to the handle, the primary shaft comprising: a primary tubehaving a generally circular cross-sectional shape and a lengthsufficient to access a target location within the body of the patient,with the primary tube comprising a wall having an interior surface andan exterior surface, the wall of the primary tube having an outerdiameter of from about 5 mm to about 25 mm and a thickness of from about0.5 mm to about 5 mm to thereby define a central lumen extending throughthe primary tube; at least one scope tube extending through at least adistal region of the central lumen, with each scope tube comprising awall having an interior surface and an exterior surface, with theinterior surface of the wall of each scope tube defining a scope lumenhaving a diameter of from about 2 mm to about 10 mm; at least twoworking tubes extending through at least a distal region of the centrallumen, with each working tube comprising a wall having an interiorsurface and an exterior surface, with the interior surface of the wallof each working tube defining a working lumen having a diameter of fromabout 0.5 mm to about 10 mm; and a primary steering section located ator near a distal end of the primary shaft, the primary steering sectionhaving a plurality of substantially longitudinally-aligned links andhaving a first condition in which the primary steering section issubstantially straight and a second condition in which the primarysteering section is substantially curved; wherein the primary shaft isflexible over substantially all of its length; a primary steering wireextending through the primary shaft and connecting the primary steeringactuator to the primary steering section; a flexible instrumentpositioned within the working lumen of one of said working tubes, theflexible instrument comprising: an instrument handle; a flexibleinstrument shaft attached at a proximal end to the instrument handle;and an end effector disposed at or near a distal end of the instrumentshaft, the end effector having a tissue engaging member configured toengage tissue at the target location within the body of the patient;wherein the instrument shaft is movable within the working lumen duringuse; and an endoscope positioned within the scope lumen of the scopetube, said endoscope comprising an insertion tube that is movable withinthe scope lumen during use.
 2. The system of claim 1, wherein theprimary steering wire lies substantially within the wall of the primarytube.
 3. The system of claim 1, wherein the primary steering wire liessubstantially within the central lumen.
 4. The system of claim 1,wherein each working lumen has a diameter of about 6 mm.
 5. The systemof claim 1, wherein each scope lumen has a diameter of from about 4 mmto about 6 mm.
 6. The system of claim 1 further comprising a secondarysteering section located at or near a distal end of the instrumentshaft, the secondary steering section having a first condition in whichthe secondary steering section is substantially straight and a secondcondition in which the secondary steering section is substantiallycurved.
 7. The system of claim 5, wherein the secondary steering sectionincludes a plurality of substantially longitudinally-aligned links. 8.The system of claim 1, wherein the instrument shaft includes a braidreinforcement member.
 9. The system of claim 1, wherein the instrumentshaft is axially and rotationally translatable within the working lumenduring use.
 10. The system of claim 1, wherein the endoscope is axiallyand rotationally translatable within the scope lumen during use.
 11. Thesystem of claim 1, wherein the end effector includes a tissue fixationdevice comprising a tie connecting a pair of tissue anchors.
 12. Thesystem of claim 1, further comprising an insufflation source in fluidcommunication with one of said working lumens.
 13. The system of claim1, further comprising an external covering having a wall thickness offrom about 0.5 mm to about 5 mm and covering at least a portion of anexternal surface of the wall of the primary tube.
 14. The system ofclaim 1, further comprising at least one auxiliary tube extendingthrough at least a distal region of the central lumen, with eachauxiliary tube comprising a wall having an interior surface and anexterior surface, with the interior surface of the wall of eachauxiliary tube defining an auxiliary lumen having a diameter of fromabout 0.5 mm to about 5 mm.
 15. The system of claim 14, wherein eachauxiliary lumen has a diameter of from about 2 mm to about 4 mm.
 16. Thesystem of claim 14, further comprising a tool inserted through theauxiliary lumen.